Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Phase II, cluster-randomised controlled trial of home-based interventions delivered using the Home Treatment Programme Advisory protocol for people with dementia

Acronym

SHIELD HTP

Study hypothesis

Those people with dementia supported at home and receiving interventions delivered using the HTP Advisory protocol will have significantly better quality of life than those receiving treatment as usual.

Study design

Primary study design

Secondary study design

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not yet available in web format. please use contact details below to request a patient information sheet

Condition

Dementia

Intervention

Intervention groupThe Home Treatment Package will function as an advisory protocol/care pathway that offers guidance on appropriate interventions for home treatment and will consist of a structured approach to need assessment and include a combined risk assessment and care-planning tool. The HTP advisory protocol will be based on the evidence collected through the Cochrane and systematic review undertaken as part of Home Treatment Programme work package 1, along with the scoping exercise of existing home treatment teams and expert and service user consultation processes undertaken as part of Home Treatment Programme work package 2. The home treatment interventions will target the needs identified for the person with dementia and their family caregiver and will include a range of approaches, such as intensive support from a mental health keyworker for observation and monitoring of the home situation, provision of increased homecare support services, access to community based services, physical screening and medical treatment, availability of aids and adaptations including the use of assistive technology, respite services, carer education, skills training, counselling and family centred therapy. The HTP advisory protocol will be compiled into a manual and training provided to the mental health keyworkers who will be providing the interventions.

Control groupParticipants randomised to the control groups will receive treatment as usual (TAU). Treatment as usual implies the person with dementia and the family caregiver will receive an acceptable standard of care as currently provided within existing Home Treatment Team (HTT) and Community Mental Health Team (CMHT) teams. Treatment as usual will therefore reflect currently accepted practice and participants will continue to receive treatment as usual from statutory and voluntary services within their locality.

The duration of the intervention is 12 months

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

1. Quality of life (QoL) for people with dementia2. Number of admissions to hospital (both psychiatric and medical)3. Number of inpatient days4. Time until care home placement5. Met and unmet needs for the person with dementia

Secondary outcome measures

1. Mood2. Behaviour3. Activities of daily living4. Service use and support networks of the person with dementia

All outcomes will be assessed at baseline, 3, 6 and 12 months.

Overall trial start date

01/04/2010

Overall trial end date

01/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical centres1.1. Have a minimum of 2 clinical areas that can be recruited to the Home Treatment Trial1.2. Be staffed by appropriately qualified and trained mental health staff such as registered mental health nurses, occupational therapists, social workers and psychologists.1.3. Provide mental health assessment and treatment to people with dementia1.4. Have access to psychiatric inpatient beds1.5. Be currently open to new referrals for people with dementia requiring mental health assessment and treatment1.6. Be willing to provide the HTP Advisory Protocol as part of the exploratory trial (minimum involvement - 80% of staff members)

2. Participants2.1. Meet the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSMIV) criteria for dementia (American Psychiatric Association [APA], 1994) including Alzheimers disease, vascular dementia, Lewy Body type dementia, atypical and mixed dementia2.2. A Mini Mental State Examination (MMSE) score <24 that indicates the presence of cognitive impairment (Folstein et al, 1975)2.3. Have a family caregiver / informant (e.g. family member, neighbour, care home staff member) willing to participate in the study2.4. Have a family caregiver / informant (e.g. family member, neighbour, care home staff member) who provides care for a minimum of 4 hours per week2.5. Have a mental health keyworker willing to participate in the study2.6. Have an appropriately qualified mental health keyworker involved in their care i.e. mental health nurse, occupational therapist, psychologist, social worker2.7. Both the person with dementia and their caregiver live within the geographical areas covered by the research2.8. The person with dementia and their caregiver will be English-speaking2.9. Have the potential to benefit from HTP Advisory Protocol interventions - implementation of the HTP Advisory Protocol should not be detrimental to the person with dementias wellbeing, such as by delaying hospital admission for those requiring immediate access to inpatient care2.10. Male or female, age >65 years2.11. In addition all participants will meet one of the following criteria:2.11.1. Are at serious risk of requiring hospital admission within the next month 2.11.2. Meet criteria for admission to an inpatient psychiatric unit

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Clinical centres 1.1. Mental Health settings that do not routinely care for people with dementia1.2. Non NHS settings, such as voluntary sector services1.3. Unable to nominate a suitably qualified and experienced senior staff to provide a clinical lead to support the mental health keyworkers1.4. Unable to nominate a suitably qualified and experienced senior staff to provide a research lead to support the mental health keyworkers

2. Participants2.1. Have a diagnosis of a learning disability 2.2. Are experiencing acute mental health distress that warrants detention under the mental health act2.3. Are refusing to accept Home Treatment interventions2.4. The person with dementia or their family caregiver is already taking part in an existing research study involving psychosocial interventions

Recruitment start date

01/04/2010

Recruitment end date

01/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL, Department of Mental Health Sciences
London
W1W7EJ
United Kingdom